Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With Ligelizumab
Study Purpose
The purpose of this extension study is to establish efficacy and safety of ligelizumab. This will be assessed in adult and adolescent chronic spontaneous urticaria (CSU) patients who have completed a preceding ligelizumab study and have relapsed, following treatment in these preceding studies, despite standard of care H1-antihistamine (H1-AH) treatment. In a subset of subjects, the safety and efficacy of ligelizumab monotherapy will be assessed. This study will also fulfill the Novartis commitment to provide post-trial access to patients who have completed studies CQGE031C2302, CGQE031C2303, CQGE031C2202 or CQGE031C1301
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 12 Years and Over |
Gender | All |
Key
Inclusion Criteria:
- - Written informed consent.
- - Subjects who successfully completed all of the treatment period and the follow-up period in any of the following studies: CQGE031C2302, CQGE031C2303, CQGE031C2202 or CQGE031C1301.
- - Male and female, adult and adolescent subjects ≥12 years of age.
- - Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedule.
Exclusion Criteria:
- - Use of investigational drugs, other than those in use in the preceding studies, at the time of enrollment.
- - Use of omalizumab within 16 weeks of Screening.
- - History of hypersensitivity to the study drug ligelizumab or its components, or to drugs of similar chemical classes.
- - New onset or signs and symptoms of any form of chronic urticarias other than CSU during the preceding studies CQGE031C2302, CQGE031C2303 or CQGE031C2202.
- - Diseases with possible symptoms of urticaria or angioedema.
- - Subjects with evidence of helminthic parasitic infection.
- - Documented history of anaphylaxis.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04210843 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Novartis Pharmaceuticals |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Active, not recruiting |
Countries | Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Lebanon, Malaysia, Mexico, Netherlands, Oman, Peru, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, United States, Vietnam |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Chronic Spontaneous Urticaria |
Arms
Experimental: Ligelizumab Dose 1 and 3
Liquid in vial 72 mg/mL followed by 120 mg/mL PFS
Experimental: Ligelizumab Dose 2 and 3
Liquid in vial 120 mg/mL followed by 120 mg/mL PFS
Interventions
Drug: - Ligelizumab
liquid in vial 120 mg/mL Prefilled Syringe 120 mg/mL
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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